FDA-Device2019-03-06Class I

icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.

ICU Medical, Inc.
Hazard

There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate

Sold states
US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.
Affected count
2050 units
Manufactured in
951 Calle Amanecer, San Clemente, CA, United States
Products
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0805-2019

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